Job Description:
The Junior Quality Engineer is responsible for the support of daily activities to maintain the quality management system, including supporting incoming inspection, calibration process, training, complaint handling, supplier quality, etc., and ensure quality standards, processes, and procedures are in compliance. The Junior Quality Engineer will also participate in cross-functional projects supporting quality and process improvement initiatives. The Junior Quality Engineer also helps to ensure Nobel Biocare’s continued regulatory compliance in accordance with the FDA CFR 820, ISO 13485:2016 and MDSAP (Medical Device Single Audit Program) and the Medical Device Regulations in the EU (MDR).
ACCOUNTABILITIES –
- Ensure exceptional service for internal customers
- Follow all procedures (SOPs) and documentation related to the Quality Management System to ensure compliance to all standards
- Support the development, revision and maintenance of procedures, documentation and standards, relevant to the Quality Management System (Incoming inspection, training, calibration, etc.) that ensure best practices and compliance
- Assist in the resolution of quality issues related to non-conformance reports, cell shutdowns, customer complaints, process performance, product performance, etc.
- Support complaint investigations and documentation activities under the guidance of senior quality personnel, according to the medical device regulations; FSA 21 CFR Part 820 and ISO 1348:2016, leading to process/product improvements
- Assist in implementing process improvements by using problem solving techniques, such as Problem-Solving Process (PSP), Variation Reduction (VRK) and continuous improvement techniques such as Value Stream Mapping (VSM), Transactional Process Improvement (TPI), and Lean/Six Sigma
- Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ)
- Lead and/or support CAPA investigations and related corrective and preventive actions
- Ensure training support and effectiveness for multiple functions throughout the organization
- Partner with functional teams to support maintenance of the QMS training program per regulatory requirements
- Assist in the reporting of effectiveness of the Quality Management System
- Provide support for internal and external audits and inspections
- Assist in ensuring department goals and objectives are reached
- Report the status of the Quality Management System and other related issues on a regular basis to the Sr. QA Engineer and/or Quality Assurance Manager
- Other duties as assigned by the Quality Assurance Manager
Job Requirements:
- Bachelor’s degree in Engineering or related field, or equivalent combined education and experience
- Minimum 1 year of experience as a Quality Engineer, or equivalent experience working with Quality Management Systems or with process/product improvements in a manufacturing environment
- Must reside withing a commutable distance to Mahwah, NJ. This is not a hybrid or remote role.
PREFERRED SKILLS:
- Prior work experience in a regulated medical device or pharmaceutical environment preferred
- Prior experience participating in regulatory audits a plus
- Prior experience managing complex data sets or statistical tools a plus
- Knowledge of quality systems and regulatory requirements applicable to medical devices (e.g., FDA QMSR/QSR, ISO 13485, MDR) preferred
- Ability to support investigations, CAPAs, nonconformances, complaints, and continuous improvement activities using structured problem-solving methodologies
- Strong analytical skills with the ability to review and interpret data, identify trends, and support data-driven decision making
- Proficiency in Microsoft Office applications; advanced Excel skills preferred
- Experience with ERP, quality management, or learning management systems preferred
- Ability to develop, review, and maintain quality documentation with a high level of accuracy and attention to detail
- Basic understanding of validation and qualification requirements for equipment, processes, and systems
- Strong communication and collaboration skills with the ability to work effectively in cross-functional teams
- Excellent organizational skills and ability to prioritize work in a fast-paced, regulated environment
- Demonstrated learning agility, initiative, and commitment to continuous improvement
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Target Market Salary Range:
Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.
$76,000 - $92,900
Operating Company:
Nobel Biocare
Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.
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